Study With Improved Solubility Pazopanib

Pharmacokinetics of Pazopanib Clinical Trial

Official title:

Proof of Principle and Pharmacological Phase 0 Study With Improved Solubility Pazopanib

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02810756
• Other study ID #: N16PZN
• Status: Completed
• Phase: Early Phase 1
• First received: May 31, 2016
• Last updated: September 8, 2017
• Start date: September 15, 2016
• Est. completion date: August 28, 2017

Study information

• Verified date: September 2017
• Source: The Netherlands Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The pharmacokinetics of a new formulation with Pazopanib will be studied. This will be done in a patient cohort of n = 12.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 28, 2017
• Est. primary completion date: August 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Locally advanced or metastatic cancer;

• Able and willing to give written consent;

• WHO performance status of 0, 1 or 2;

• Able and willing to undergo blood sampling for PK analysis;

• Minimal acceptable safety laboratory values;

• Negative pregnancy test for female patients with childbearing potential;

• Able and willing to swallow oral medication.

Exclusion Criteria:

• Any treatment with investigational drugs within 30 days prior to receiving the investigational treatment;

• Any treatment with CYP3A4, BCRP or PGP interfering drugs;

• Patients who received treatment with Votrient(R) kess than 1 week ago;

• Woman who are pregnant or breast feeding;

• Patients suffering from any known condition that may influence the dissolution or absorption of Pazopanib.

Related Conditions & MeSH terms

• Pharmacokinetics of Pazopanib

Intervention

Drug:
• New Pazopanib formulation

Locations

Country	Name	City	State
Netherlands	Netherlands Cancer Institute	Amsterdam	North Holland

Sponsors (1)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentration	Concentration of pazopanib in plasma	24 hours
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	1 week
Secondary	Area under the plasma concentration versus time curve (AUC)	Area under the plasma concentration versus time curve (AUC)	24 hours